Manufacturing Engineer II

Title: Manufacturing Engineer II

Location: St. Paul, MN

Duration: 7 Months

Shifts: 8AM TO 4:30PM

100% Onsite

Summary

The Contract Manufacturing Engineer II applies technical expertise and knowledge of manufacturing systems to support Abbott’s business objectives. This role plays a proactive part in contract manufacturing operations, focusing on validation, process improvement, and quality system execution within a regulated medical device environment.

The engineer collaborates cross-functionally to ensure robust manufacturing processes, compliant documentation, and successful validation activities supporting tissue heart valve and delivery system products.

Key Responsibilities

• Lead and execute validation activities, including:

1. Process Validation (PV)
2. Software Validation
3. IQ (Installation Qualification)
4. OQ (Operational Qualification)
5. PPQ (Performance Qualification)

• Develop, author, and maintain quality system documentation, including:

1. Validation protocols and reports
2. Manufacturing instructions
3. Test methods and technical documentation

• Support engineering change activities, including:

1. Print updates using SolidWorks
2. Process and inspection updates
3. Document control within systems such as Windchill

• Partner with cross-functional teams (Manufacturing, Quality, Regulatory, R&D) to:

1. Execute validation and process improvement initiatives
2. Support ongoing production and issue resolution
3. Ensure compliance with applicable regulatory and quality standards

• Work directly with production personnel in a cleanroom environment to:

1. Support implementation of validated processes
2. Troubleshoot manufacturing challenges

• Contribute to process development activities, including:

1. Supporting or leading development efforts in lab environments
2. Evaluating and implementing process improvements

• Identify and anticipate technical challenges; develop and recommend solutions where standard practices may not exist
• Apply structured problem-solving and sound engineering judgment, considering broader system impacts
• Participate in peer reviews of engineering work, validation strategies, and documentation
• Support broader team and organizational initiatives as needed

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.